Fu TCM Patent - justinhughes.net · It is noted that the term ... meaning “pattern differentiation and treatment determination ... It is regarded that the medical effect of a TCM

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Examining the Compatibility between the Patent Law and Traditional Chinese Medicine:

From the Perspective of Identifying TCM in Patent Application

Part I: Introduction

In the WHO report, the traditional Chinese medicine (TCM) is regarded as one of the four

major traditional medicine systems, namely traditional Chinese medicine, Indian

ayurveda and Arabic unari medicine, and various forms of indigenous medicine,1 in

which TCM shares with other forms of traditional medicine some common philosophic

and physical features.2 The traditional Chinese medicine has a long history of practice in

the world, especially in areas like Mainland China, Taiwan, Japan and Korea. TCM

represents the medical practice that is based on Chinese traditional philosophy that

contains the concepts like “Qi”, “Yin & Yang”, “Five Elements” and “Bian Zheng Lun

Zhi”,3 and its chemical therapy is normally made from the combination of animal,

1 WHO/EDM/TRM/2001.1. “Report of the Inter-Regional Workshop on Intellectual Property Rights in the

Context of Traditional Medicine.”

2 See ibid. For instance, TCM and other traditional medicine use combination of herbal materials to cure

illness and take systematic view on the human body. Some of the common features make it possible to

discuss the application of patent law on TCM by looking at its application on other traditional medicine.

3 Liu, Zhan-wen. 2002. “Philosophical Aspects Of Chinese Medicine From A Chinese Medicine

Academician.” In The Way Forward For Chinese Medicine. Eds. Kelvin Chan and Henry Lee: TAYLOR &

FRANCIS. It is noted that the term “Bian Zheng Lun Zhi” is sometimes expressed as “Bian Zheng Shi Zhi”

in Chinese.

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mineral and plant origin4. The theoretical basis and the physical properties of TCM

distinguish it from western medicines.

With the increasing popularity of traditional Chinese medicine, the relationship between

the patent law and traditional Chinese medicine has, in the last decade, been highlighted

by the boom of patents granted to traditional Chinese medicine worldwide. Most

countries have been examining the TCM inventions under the same guidelines for

chemicals and pharmaceuticals.5 However, as TCM is special in both physical features

and medical theory, it is often difficult for it to fit in the current framework of patent law

that is designed for western chemicals and pharmaceuticals. The difficulties in patenting

TCM inventions raise the fundamental issue of the compatibility between the patent

system and TCM inventions. In practice, when applying their patent examination

guidelines to TCM countries have been taking different approaches to various

patentability issues, which results in divergent attitudes on the patentability of TCM. In

general, the examination practices of western countries, like US and EU countries, have

showed to be more stringent to Asian regions like Mainland China and Taiwan.

Considering the special features of TCM and its rapid development, the Taiwan

Intellectual Property Office introduced a special Chapter for examination of TCM

inventions in its Guideline, which remains as the only guideline in the world specifically

tailored for TCM patent examination.6

4 Chan, Kelvin. 2002. “The Historical Evolution Of Chinese Medicine And Orthodox Medicine In China.”

In The Way Forward For Chinese Medicine. Eds. Kelvin Chan and Henry Lee: TAYLOR & FRANCIS.

5 Taiwan is the only exception where the Patent Examination Guideline has a special chapter for TCM

examination.

6 See 台湾专利审查基准汇编, 第二编, 第十二章. The chapter, named “Examination Guideline for

Traditional Chinese Medicine”, was introduced in the 2007 version of the Taiwan Patent Examination

Guideline. (see Taiwan IP Office website:

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The article observes compatibility issue from the perspective of identification of TCM

inventions in the patent application. Patent law requires that an invention needs to be

defined in the specification in a clear and precise way. Currently, TCM inventions are

identified mainly by three methods: effective compounds, physical properties or the

product-by-process claim. The article examines how those methods have been used in

countries’ practice and in what extant the methods are suitable for TCM inventions.

Part II of the article will discuss the concept of traditional Chinese medicine and

introduce the identification issue. Part III focuses on the identification of TCM in patent

law. Part IV provides some suggestions and gives conclusion.

Part II: Traditional Chinese Medicine and Its Identification Problem in Patent Law

1. Concept of Traditional Chinese Medicine

The word “traditional” is in some extent misleading, which delivers the image that all

traditional Chinese medicines are old and, thus, unsuitable for patent protection. The term,

“traditional Chinese medicine”, was first used in 1950s in foreign language magazine to

http://www.tipo.gov.tw/ch/AllInOne_Show.aspx?path=447&guid=e3de95be-d2f5-427a-a340-b2c8d7e4a60

f&lang=zh-tw )

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refer to the Chinese medical practice as distinguished from western medicine.7 In fact,

the traditional Chinese medicine is an evolving system that is neither unchanging nor

unchanged.8 The “new” traditional Chinese medicines developed by the industry have

been attaining patents worldwide.9

The features of traditional Chinese medicine in comparison with western medicine can

mainly be discussed from the perspectives of both medical theory and physical properties

of medicine.

The traditional Chinese medicine views human body as an inner-related system and treat

the disease under this guidance. The essential principle of it is the theory, “Bian Zheng

Lun Zhi”, meaning “pattern differentiation and treatment determination”10

. The traditional

Chinese medicine takes the view that a certain pattern of disease is the reflection of

disorder of human organism.11

Therefore, the root of the disease may lies in other parts

of the body where the medical treatment should be directed toward. However, western

medicine intends to apply treatment directly to the disease. One common opinion

regarding to the theoretical difference between traditional Chinese medicine and western

7 Volker Scheid, Chinese Medicine in Contemporary China, Duke University Press (2002), Page 3

(Introduction part). In this sense, as pointed out in the book, the term “traditional Chinese medicine” was

used in the same meaning as “Chinese medicine”.

8 Volker Scheid, Chinese Medicine in Contemporary China, Duke University Press (2002), Page 3

(Introduction part).

9 Even for “old” traditional Chinese medicine, there is still some room for patenting. For example, some of

the Miao yao, one particular type of traditional Chinese medicine, have been kept in the local minority

group – the Miao group – during the history of whole practice, and are arguably able to meet all three

criteria of patent examination. The “old” traditional Chinese medicines are not in the scope of the

discussion of the article.

10 Volker Scheid, (2002) Chinese Medicine in Contemporary China, Duke University Press, Page 200.

11 Ibid.

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medicine is that “Chinese medicine treats the root while western medicine attends to

manifestations.”12

Under the guidance of its theories, the traditional Chinese medicines are developed to

treat the body as a whole. The medicines of TCM can be generally divided into two

groups – single prescription and complexity prescription – depending on the number of

natural materials used in the production of the medicine.13

Most of the western medicines

have clear chemical structure, or composed of effective agents, whereas medicines of

TCM are far more complex in their chemical components.14

2. The Identification Problem

The patentable subject matters of TCM include process and product. The patentable TCM

processes can range from the cultivation of raw materials to manufacture process of

medicine.15

Although there are controversial views on whether some of the TCM

processes may be regarded as diagnostic or therapeutic process and, therefore, not

patentable16

, TCM process will not cause difficulty in identification of the invention.

12

Ibid.

13 朱晟何端生 (2007) “中药简史” 广西师范大学出版社. The single prescription contains only one

type of TCM materials. For example, ginseng alone can be used to produce a TCM. The complexity

prescription, however, is composed of more than one type of materials.

14 孔宪泽詹华强. 2006. “从西方思维看中药现代化.” 三联书店, pp 59 – 61.

15 肖诗鹰刘铜华，（2005）“中药知识产权保护和申报技术指南”，中国医药科技出版社，pp 39 – 40.

16 See 肖诗鹰刘铜华，（2005）“中药知识产权保护和申报技术指南”，中国医药科技出版社，pp 41

– 42.

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As mentioned above, medicines of TCM include single prescription and complex

prescription. The combination formulas of complex prescription alone may also become

the subject matter of patent. A TCM practitioner usually writes down the combination

formula as the prescription according to the particular situation of the patient, who would

then get the combination of the medical herbs according to the formula and make the

medicine, e.g. medical soup, himself. It is regarded that the medical effect of a TCM is

mainly decided by its formula.17

The TCM formula is the combination of natural

materials, the quality of which largely depends on natural conditions such as the

geographic origin or harvest season.18

Disclosure of that information of an invention is

important for others to realize it. However, the western standard of medicine may go one

step further to ask for the disclosure of the effect agents contained in each type of the

natural material.

A TCM medicine is normally unclear in its chemical structure or even unknown in its

effective agents. This feature makes TCM difficult to enter the western market as

medicine.19

To modernize the TCM to meet the western standard, the TCM industry has

been trying to identify and extract the chemicals or effective components from the TCM

medicines. Those extractions can either be defined with chemical formula or effective

agents. However, it is argued that the western approach may reduce the medical effect of

TCM, because a single effective agents target only one part of body, and under the

17

张仁平, 台湾中草药保护之回顾与前瞻（下），智慧财产权月刊 90年 12月.

18 See台湾专利审查基准汇编, 第二编, 第十二章, 3.3.1.2.

19 See 张成文等, 植物提取物是中药走向国际市场的现实表达方式 (陈冲主编, 中药现代化研究,

(2006) 化学工业出版社, pp 88 – 96.) Currently, most TCM medicines are marketed as food or nutrition in

the western market.

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guidance of systematic view the medical effect of the TCM medicine works the best when

all TCM medicine works as a whole to the body.20

It is the universal principle of patent law that the applicant must disclose the invention in

a precise and clear way so that a person skilled in the art may be able to realize it.21

To

define the TCM medicines in the specification, there are mainly three ways: define it by

chemical formula or effective agents, by physical properties, and by the

product-by-process claim. The countries’ practice of using those methods in defining

TCM show that their attitudes of the methods is, in fact, resulted from standard of western

medicine.

Part III: Identify TCM in the Specification

1. Identify by Chemical Formula

When a substance is defined by chemical formula, the disclosure is unambiguous and

there will not be any construction problem in the latter stage of enforcement. One

approach of modernization of TCM is called “Chinese-Western medicine integrated

approach”22

. Under the approach, experimental methods are run on the medicines of TCM

20

张仁平, 台湾中草药保护之回顾与前瞻（下），智慧财产权月刊 90年 12月.

21 See e.g. 35 U.S.C 112 Specification.

22 Eric Ziea & Joseph Sung, Irritable Bowal Syndrome: A Chinese-western integrative approach for

treatment, See the website of Hong Kong Jockey Club Institute of Chinese Medicine:

http://www.hkjcicm.org/5news/3/1.asp . (visited at 21 Dec. 2008.)

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to find out the bio-effective compound or composition. The medicines achieved by the

method fits the western medical point of view, and some of them can be defined by

chemical structure. For instance, the US patent, “compounds for use in the treatment of

skin conditions”, is the extract from the herbal material, black pepper, and the product

claim was defined by chemical formula.23

However, as most TCM medicines or herbal materials are very complex in chemical

composition, it is difficult to locate and extract the bio-effective chemical compounds.24

Currently, the method of identifying by effective compounds has not been widely used in

the TCM patent application.

2. Identify by Physical Properties

Most countries allow a substance to be defined by its physical properties. For instance, in

the EPO patent examination guideline, a product may be defined by “parameter” of

“characteristic values” such as melting point of a substance, the flexural strength of steel

and the resistance of an electrical conductor, etc.25

In some regions, the method is

restricted to the situation when the product can not be defined by physical structure.26

23

US Patent Number 7,361,685.

24 郑永锋，中草药专利问题探讨，《中药、草药专利审查基准之研究、增订及利用中医辨证作为审查可行性之探讨》．

25 EPO Patent Examination Guidance, Chapter III paragraph 4.11.

26 For instance, EU and Taiwan.

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The western approach of TCM research mentioned above has been used to identify the

effective agents of TCM medicine. Some of those effective agents are single chemical

compounds, whereas the others are compositions where the effective compounds can be

identified as the inventive substance27

.

When the bioactive ingredients are identified, defining a TCM medicine is essentially the

task of defining the effective compounds. This is because a composition can be defined

by the inventive compounds contained in the composition.28

The method of identification

by physical properties has been widely used as the approach to define a compound of

unknown structure.29

In the US patent, “pharmaceutical composition for the treatment of

cardiovascular and cerebrovascular disease”, the composition was consisted of effective

compounds, which were further defined by the physical properties of each compound.30

The invention is composed of four herbal components, namely Radix Saldix Miltiorrhizae

extract, Radix Notoginseng extract, Radix Astragali extract and Borneol or oil of Lignum

Dalbergiae Odoriferae. Each extract was defined by effective compounds. For example,

the Radix Saldix Miltiorrhizae extract was claimed to comprise 45%-70% salvianolic acid

B, 2%-10% salvianolic acid E, 4%-20% rosmarinic acid, 1%-10% lithospermic acid, and

more than 70%, preferably more than 80%, salvinolic acids.31

However, as some of the

compounds, for instance, salvianolic acid B, are complex in its structure, various

27

A composition is essentially the invention of the compound, which contains the inventive steps. (See

Grubb, Patent for Chemicals, Pharmaceuticals and Biotechnology, (2004), Oxford. Pp 226 – 227.)

28 See Grubb, Patent for Chemicals, Pharmaceuticals and Biotechnology, (2004), Oxford. Pp 226 – 227.

29 See Grubb, Patent for Chemicals, Pharmaceuticals and Biotechnology, (2004), Oxford. Pp 220 – 221.

30 US Patent Number 7,438,935.

31 Ibid.

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parameters, like wavelength, mobile phase and theoretic plates, were used to define the

physical properties of it.32

However, for TCM medicines, the effective compounds are not clear since the chemical

composition of them are so complex that it is difficult to identify the bioactive

compounds.33

When the effective compounds of a TCM medicine are difficult to identify,

the approach that has been introduced in Taiwan and Mainland China is to define the

physical properties of the medicine as a whole. In the Taiwan examination guideline for

TCM, it is stated that a TCM extract may be defined by the physical properties, chemical

properties or other characteristics.34

The physical or chemical properties include

molecular weight, melting point, ultraviolet spectrum, molten point, etc.35

Those indexes

can be used in associate with the fingerprint36

of the extract to give a full overall

illustration of the physical and chemical characteristics of the TCM medicine.

Although the bioactive compounds are not identified, the method probably suits the

features of TCM, which takes a systematic approach to treat disease. The complexity of

the chemical composition and the chemical reactions among them are regarded to be

important for the TCM medicine. By identifying the main components of a TCM

medicine, the method suits the special features of TCM.

3. Identify by the Product-by-Process Claim

32

Ibid.

33 See 张仁平, 台湾中草药保护之回顾与前瞻（下），智慧财产权月刊 90年 12月.



36 Fingerprint of the extract provide the types of the chemical components contained in the extract.

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A product-by-process claim defines a product by the method of production.37

A

product-by-process claim is still a product claim, in which the patentability is solely based

on the product instead of the process used to describe the product.38

The creation of product-by-process claim suits the products that cannot be identified in

physical structure. In reality, the product-by-process claim has been frequently used on

pharmaceutical and chemical inventions.39

The necessity of such type of claim is

perfectly justified for the pharmaceutical industry by the fact that millions and billions of

dollars have been dumped into the research of pharmaceutical and chemical drugs, a great

amount of which can not be defined by structure.40

In practice, the controversy about the product-by-process lies mainly in two issues: the

rule of necessity (whether the product-by-process claim can only be used on products that

cannot be identified other than process) and the protection scope of such a claim (whether

process used to define the product should be used to limit the protection scope).

37

MPEP 2113.

38 See, for example, MPEP 2113.

39 Mark D. Passler, Product-By-Process Claims: Majority of the Court of Appeals for the Federal Circuit

Forgets Purpose of the Patent Act, 49 U. Miami L. Rev. 233.

40 It is revealed in Passler’s article that the average research spending to discover one new chemical

compound of the pharmaceutical companies in 1990 was 230 million USD and only one out of every 5,000

or 10,000 of the compounds could eventually enter the market. (see Mark D. Passler, Product-By-Process

Claims: Majority of the Court of Appeals for the Federal Circuit Forgets Purpose of the Patent Act, 49 U.

Miami L. Rev. 233, footnote 4.)

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3.1. Deficit of the Product-By-Process Claim

There are generally two types of patents: product and process. The product-by-process

claim was essentially a product claim,41

in which the process described is not subject to

protection. However, instead of defining a product by physical properties or function, it

describes the product with the process of producing. Although this feature of the claim

helps to define the product inventions that can not be defined in the way other than

process, it also gives rise to various problems.

All controversies about the product-by-process claim have the common root on the

deficiency of the claim that, although the product-by-process claim is a product claim, it

by its nature does not disclose what the product actually is.42

This first gives troubles to

the patent construction of the courts.43

The courts would have problems of figuring out

what the product exactly is by reading through the process and specification, which may

not provide the structural or physical properties of the product. As the result, the courts, as

evidenced in the US, would sometimes regard the process as limitation to the product and

41

Although the case law of the US show controversy on whether the process in a claim should be used to

constrict the scope of protection, there is no conflict on the issue that the subject matter of a

product-by-process claim is the product. (see e.g. Atlantic Thermoplastics Co. v. Faytex Corp, 970 F.2d

1279 (Fed. Cir. 1992) at 845. In the case, the court noted that a product-by-process should be examined

based on the product itself even though it decided that the process language in the claim should limit the

scope of the protection.)

42 Gary Newson, Product-by-Process Patent Claims: Arguing for a Return to Necessity and Reduction in

the Scope of Protection, 40 Ariz. St. L.J. 327.

43 Greory S. Maskel, Product-By-Process Claim Construction: Revolving the Federal Circuit’s Conflicting

Precedent, 17 Fordham Intell. Prop. Media & Ent. L.J. 115.

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do not in other occasions.44

The deficiency would also create the unclear shore between

the claimed product and other products that are made by different process. A researcher

may have idea of what had been created by the recited process, but it would be difficult

for him to tell the differences between the two products if the other product is made by a

new process.45

Clearly, those problems will challenge the whole patent system in various

aspects of both patent examination and the courts proceedings. It is, therefore, no doubt

that the CCPA had “consistently stated” that the general rule of claiming an article was by

its physical structure not by its manufacturing process.46

3.2. Rule of Necessity

The rule of necessity established that the product-by-process claim can only be used when

the product cannot be properly defined and discriminated from the prior art otherwise

than by reference to the process of producing it. The principle has followed in many

countries or regions, for instance, EU, Mainland China, and Taiwan. In the US, the

44

It was argued that the US courts’ controversy on the construction of the product-by-process claim lies in

the fact that sometimes the process may be more important to identify what the product is, while sometimes

it does not. Thus, the courts would tend to use the process as limitation to the scope of right when it does

not give much information on what the product is. (see, Greory S. Maskel, Product-By-Process Claim

Construction: Revolving the Federal Circuit’s Conflicting Precedent, 17 Fordham Intell. Prop. Media & Ent.

L.J. 115.)

45 Gary Newson, Product-by-Process Patent Claims: Arguing for a Return to Necessity and Reduction in

the Scope of Protection, 40 Ariz. St. L.J. 327.

46 Atlantic Thermoplastics Co v. Faytex Cor., 970 F.2d 834; 1992 U.S. App. LEXIS 15888; 23 U.S.P.Q.2D

(BNA) 1481.

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principle was first established in the In re Painter case47

. However, after that, a number of

cases had departed from the rule of necessity.48

In 1974 the PTO modified the

Examination Manual, which stated that a product-by-process would be permitted so long

as it satisfies the requirement of Section 112 of the Patent Act – the definiteness

requirement.49

It was not until then, was the rule of necessity officially abolished for the

product-by-process claim in the US.

To the product-by-process claim, the effect of the rule of necessity is essentially to

constrain the scope of applicability of the claim by excluding the products that can be

defined by other means. Also, the reasonable expectation of what the invention actually

covers would be improve by encouraging the applicants to define articles with physical

structures, which will also benefit the court proceeding on patent construction50

and

prevent the applicant to use the product-by-process claim as the hedge against the

possibility of invalidation of the broader product claim.51

However, the rule of necessity will also impose a heavy burden on an applicant who has

to prove that no other way is available for identification. As most TCM medicines are

47

Lawrence A. Hymo and Richard A. Anderson, Product-By-Process Claims: Time for Reexamination,

132 The Federal Circuit Bar Journal, Vol. 3 No. 2 Summer 1993.

48 Examples can be see in the following cases: In re Pilkington (411 F.2d 1345 (CCPA 1969)), the court

stated that Congress placed no limitation on how an applicant claim his invention; In re Hughes (496 F.2d

1216, 1218 (CCPA 1974)), the court recognized the right of the applicant to define the product by the

process even though it may be defined in terms of structure and characteristics; In re Steppan (394 F.2d

1013, 1019 (CCPA 1967)), the court pointed out the rule of necessity was not supported by the patent

statute.

49 See MPEP (version 1974), 706.03 (e).



51 In re Hughes, 496 F.2d 1216, 1219; 1974 CCPA LEXIS 155; 182 U.S.P.Q. (BNA) 106.

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complex in structure, imposition of the principle may cause redundant burdens in the

patent applications.

3.3. Process Limitation to the Scope of Protection

Although it is agreed that the patentability of a product-by-process claim is solely decided

on the basis of the product itself, it is not clarified in the patent examination manual of

any country whether the making process would constitute limitation in the infringement

test.

The rationales of both side can be observed in the two US cases: Scripps Clinic v

Genentech Inc and Atlantic Thermoplastic Co v Faytex Corp.52

In the Scripps, the patent

owner, Scripps Clinic, held the protein patent, Factor VIII:C, that was claimed by the

process of chromatographic absorption, and the respondent, Genentech Inc, later

produced the protein using the process of recombinant-DNA techniques. The court ruled

on the infringement of the protein patent, despite the fact that Genentech Inc has

manufactured it with different process.53

The Scripps case was decided in 1991. Six

months later, however, the Federal Circuit decided on the Atlantic case, in which the court

regarded the process as the limitation to the patent and overruled the infringement claim.

The Atlantic case was about a shock absorbing innersole claimed by a product-by-process

52

In fact, before the two cases, no Federal Circuit case had addressed the issue of whether a process would

constitute a limitation to the product-by-process claim. (Mark D. Passler, Product-By-Process Claims:

Majority of the Court of Appeals for the Federal Circuit Forgets Purpose of the Patent Act, 49 U. Miami L.

Rev. 233, 246.)

53 Scripps Clinic v Genentech Inc, 927 F.2d 1565, 1583.

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claim. In the case, Atlantic Thermoplastic, sued the respondent, Faytex Corp, for

manufacturing the innersole. This time, the court overruled the infringement claim on the

ground that the production process of Atlantic Thermoplastic constituted limitation to the

patent and Faytex Corp did not commit the infringement since the manufacturing method

of it was different from what Atlantic Thermoplastic claimed in the patent.54

In the later

district court cases, some courts followed the first precedent while others followed the

second.

The rational of the Scripps case was that the patentability of a product-by-process claim

should be decided solely on the product instead of process.55

The court held that

patentability and infringement should be examined on the same standard, and, therefore,

the process provided no limitation in the infringement analysis.56

Taking a divergent

approach as the Scripps panel, the Atlantic court, based its conclusion by examining a

number of the Supreme Court cases and academic literature,57

noted that even though the

patentability of a product-by-process claim was based on the product itself,58

the

product-by-process claim would not be infringed unless the same process was used in the

production.59

It is criticized that if the process provides no limitation to the scope of right, problems

will be created in the stage of claim construction. By focusing solely on the product the

approach ignores the meaning of the claim by excluding the part of description of

54

Atlantic Thermoplastics Co v. Faytex Cor., 970 F.2d 834, 838, 839.



57 See Atlantic Thermoplastics Co v. Faytex Cor., 970 F.2d 834, 838 – 843.

58 Atlantic Thermoplastics Co v. Faytex Cor., 970 F.2d 834, 845.

59 Atlantic Thermoplastics Co v. Faytex Cor., 970 F.2d 834, 845.

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process.60

As the result, the general rule was broken that “every limitations and its

equivalent” of a claim need to be represented in the accused behavior.61

The practical

problem is also caused when the product cannot be adequately defined by physical

properties. It will, thus, be difficult to know what the product really is and decide on the

infringement.62

However, if the process in the claim is used to as limitation, it will render

the product-by-process claim a de facto process claim.63

. The product-by-process claim

was supposed to provide incentives to industries where new products are difficult to be

defined other than process. The introduction of the product-by-process claim as an

exception to the general rule of identification is a “pragmatic adjustment to the needs of

science, not law.”64

Undoubtedly, the Scripps approach that ignores the process limitation

can provide wider scope of protection and incentive of invention for the industry.65

The technical features of TCM mainly lie in the types and proportion of the materials

used in the composition.66

Thus, the disclosure of the composition of materials is

important for the enablement of the invention. However, in the infringement disputes of

TCM inventions, the situations often appear to be that a respondent made minor

modification to the original combination and marketed the medicine for the same medical

purpose as the patented TCM medicine. As the minor modification to the TCM

60

Greory S. Maskel, Product-By-Process Claim Construction: Revolving the Federal Circuit’s Conflicting


61 Smithkline v Apotex, 439 F.3d 1312. (Judge Newman Dissenting at 1321)



63 This is especially true in determination of infringement, given the fact that in most jurisdictions a process

patent will also cover the product that is directly made by it.

64 Smithkline v Apotex, 439 F.3d 1312. (Judge Newman Dissenting at 1321).



66 See张仁平, 台湾中草药保护之回顾与前瞻（下），智慧财产权月刊 90年 12月.

18

combination will not change the medical effect of the final medicine in great deal,

recognition of the process limitation in the infringement test would hurdle the patent

enforcement of TCM inventions.

It is proposed that the principle of equivalence should be used in dispute to determine the

infringement between the two TCM medicines made from the two sets of combinations

with minor difference.67

When employed, the principle is proposed to be guided under

the TCM theory to explain whether two medicines from the similar combination have the

same medical effect and can be regarded as the same medicine.68

3.4. TCM and the Product-by-Process Claim

Currently, most TCM inventions are defined by the product-by-process claim. This is

partly because of the complex chemical structure of TCM medicines, which make them

difficult to be defined by any other means. However, to TCM medicines, the

product-by-process claim may not be the last option. It is regarded that the

product-by-process claim can best suit the technical features of TCM medicines. Guided

by the principle of “Bian Zheng Lun Zhi”, TCM treats the human body as an inter-related

entity.69

Therefore, the complex chemical composition that resulted from the chemical

reactions among the herbal or animal materials is important to carry out the medical effect

of TCM. In fact, research has shown that some purified medical compounds from TCM

67

See 游云, 中药复方专利保护及其侵权分析, 中国中医科学院 2003级博士论文, pp 48 – 50.

68 See 游云, 中药复方专利保护及其侵权分析, 中国中医科学院 2003级博士论文, pp 48 – 50.

69 Volker Scheid, (2002) Chinese Medicine in Contemporary China, Duke University Press, Page 200.

19

medicines are not as effective as the original medical compositions.70

The western

approach of extracting bio-active compounds from TCM, although suits better the

requirement of definiteness of claim, may cause some TCM medicines to lose the original

features.

The controversy of the product-by-process claim is essentially arisen from the deficit that

a product-by-process claim may not be able to clearly depict the physical structure of the

product. While the product-by-process claim was introduced to provide incentive to

certain industries, especially those where the products cannot be defined by physical

property, it also creates problems to the definiteness of the claim. The debate of the

process limitation represents the conflict between the encouraging invention on one side

and general principle of patent system71

on the other side.

To an industry, for instance the TCM industry, with heavy R&D expense and where the

products are difficult to be identified by physical properties, the process limitation would

severely impede the innovation of the industry. Therefore, under this circumstance, it is

appropriate to grant broad protection to the claim and shift the task of claim construction

to the later court proceedings.72

70

See张仁平, 台湾中草药保护之回顾与前瞻（下），智慧财产权月刊 90年 12月.

71 The product-by-process claim has long been regarded as an exception to the general principle of the

paten law, which traditionally defines a product by physical properties. (see Smithkline v Apotex, 439 F.3d

1312. (Judge Newman Dissenting at 1321, 1322))

72 It is possible that, at the later stage of court proceeding, the development of technology may be able to

define the product or identify the different properties between the two products. (see Gary Newson,

Product-by-Process Patent Claims: Arguing for a Return to Necessity and Reduction in the Scope of

Protection, 40 Ariz. St. L.J. 327, 340 – 341.)

20

4. Conclusion

The patent reports from various countries show divergence in the identification of TCM

inventions between countries with TCM tradition and countries with western medical

tradition. In regions like US and EU, the applicants intend to define the TCM inventions

by the bioactive compounds, whereas in Mainland China and Taiwan the patent reports

show a relax standard which can be fulfilled by defining the main components of a TCM

medicine. The divergence of the practice is probably rooted in the different medical

traditions and the requirements of market approval resulted from it. For instance, in the

US, the applicant has to identify the bioactive compound of a medicine and explain the

medical mechanism, in order to attain the market approval.73

However, due to the

complex chemical composition of TCM medicine, it is usually difficult to find out the

mechanism of the medicine.

It can also be seen from the identification of TCM inventions that the TCM industry

brings challenges to definiteness of the patent system. As been discussed above, although

the western approach has been introduced in the TCM research, it is still difficult to locate

the medically effective compounds in a TCM medicine. In the patent application, a large

number of TCM medicines are defined by the product-by-process claim. In the

About science advancement will help to define the physical properties – (see Scripps, the science

advancement may diminish the need of filing a product claim by process. – cited in the Smithkline, 1323.

Also, in Scripps, the protein was a novel substance with unclear structure.)

73 See, for example, US Guidance for Industry Botanical Drug Products, June 2004.

21

infringement dispute, the courts will have trouble to construct the claims of TCM

medicines and determinate the infringement.

The development of TCM is based on its unique theory that distinguished from western

medicine. Although the western approach of medical research helps to identify the

effective compounds and explain the medical mechanism, it goes apart from the

theoretical basis of TCM and may decrease the medical effective of TCM medicine.

Therefore, the practice of patent law should give special concern to the features of TCM.

One way of it is to allow the methods of identification that can best keep all main

components within the patent claim as shown in the Taiwan patent examination guideline.

The compatibility issues between the patent law and TCM, especially the fact that it is

often difficult to determine the infringement of TCM inventions, also raise the question

that whether patent law can alone take the task of protecting TCM inventions. For

instance, it can be found in practice that many TCM practitioners have their own

prescriptions, which are kept as trade secret. The challenges to the patent law brought by

the TCM urge more legal forms, such as administrative law, trade secret law, and other sui

generis laws, to cooperate to protect TCM inventions.

Fu TCM Patent - justinhughes.net · It is noted that the term ... meaning “pattern differentiation and treatment determination ... It is regarded that the medical effect of a TCM

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